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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06330142
Other study ID # 2022-006
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date December 15, 2025

Study information

Verified date March 2024
Source Institut de cancérologie Strasbourg Europe
Contact Valérie SARTORI
Phone 368767223
Email v.sartori@icans.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department. The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion.


Description:

Electro-radiology medical technician (ERMT) are privileged contacts with children. They accompany them every day during radiotherapy sessions. An animal-mediated approach would provide a new out-of-hospital environment. The equine sessions, precious moments when the child can forget about his illness, would enable him to escape from his condition as a patient. Indeed, the sick child adopts a posture to withstand treatment and take on responsibilities such as "not crying" and "being brave". These moments, away from the hospital, are essential to the smooth running of care, since they limit the weariness induced by daily radiotherapy sessions and help preserve the quality of caregiver/child cooperation during treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date December 15, 2025
Est. primary completion date December 15, 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: - Children aged 8 to <18 years. - With an indication for radiotherapy for cancer (of any type) - Patients hospitalized and/or managed on an ambulatory basis - WHO = 2 - Child and parents (or accompanying adults) who speak and understand French - Free, express and informed consent of the adult patient OR of those exercising parental authority for minor patients - Child with social security coverage Exclusion Criteria: - Children afraid of horses and stables - Contraindication to the practice of equine-assisted therapy (allergy to horses or dust, children with asthma attacks triggered by dust/animal hair ...) - Patient on stretcher - Children or parents (or carers) with significant cognitive impairment, making self-assessment or hetero-assessment impossible even with assistance - Unavailability or lack of interest in participating in equine-assisted therapy sessions

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Participation in 10 horse-assisted therapy sessions
supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach

Locations

Country Name City State
France Institut de Cancerologie Strasbourg Europe Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy The questionnaire used to assess quality of life will be completed by the child.
Two versions of the VSP-A questionnaire exist, depending on the child's age (versions < 10 years and 10-17 years).
Results can be compared with reference values for the general population.
before radiotherapy, halfway through the HAT sessions (at 5 weeks), at the end of the HAT sessions (at 10 weeks) and one month after the end of the HAT sessions
Secondary Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT Parents (or carers) will complete a questionnaire to assess their child's quality of life. before radiotherapy, halfway through the HAT sessions (at 5 weeks), at the end of the HAT sessions (at 10 weeks) and one month after the end of the HAT sessions
Secondary Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT The questionnaire used to assess anxiety will be completed by the child (SCARED child version) before radiotherapy, halfway through HAT sessions (at 5 weeks), at the end of HAT sessions (at 10 weeks) and one month after the end of HAT sessions
Secondary Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT Parents (or carers) will also complete a questionnaire to assess their child's anxiety (SCARED parents' version) before radiotherapy, halfway through HAT sessions (at 5 weeks), at the end of HAT sessions (at 10 weeks) and one month after the end of HAT sessions
Secondary Assessing the acute side effects of radiotherapy at the start and end of irradiation Evaluation of acute toxicities induced by radiotherapy CTCAE version 5 scale at the start and end of radiotherapy sessions (from 3 to 7 weeks)
Secondary Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse Study the link between the various equestrian activities and the quality of life reported by children. Dashboard to track the duration of each activity carried out per child and per session, completed by the equestrian. At every HAT sessions (up to 10 weeks)
Secondary Evaluate participant's expectations and satisfaction with their care questionnaire at the beginning and end of HAT sessions (up to 10 weeks)
Secondary Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation MERT's assessment of the impact of HAT on the child's well-being, based on a retrospective questionnaire for the previous week. every week during radiotherapy (from 3 to 7 weeks)
Secondary Assessing the impact of HAT on the child during irradiation according to the MERT at each radiotherapy session (from 3 to 7 weeks)
Secondary Evaluate the rider's impression of the child's well-being of the child during HAT sessions Equestrian appreciation of the impact of HAT on the child's well-being during HAT sessions using questionnaires at the end of the first session and at the end of the last session of HAT (up to 10 weeks)
Secondary Assessing the impact of an alternative activity on parents' satisfaction with care Open questionnaire at the end of HAT to be completed by parents at the end of the HAT sessions (at 10 weeks)
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